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Prospective, multicenter, randomized controlled clinical trial of stent positioning system for assisting interventional treatment of aorto-coronary ostium lesions

Prospective, multicenter, randomized controlled clinical trial of stent positioning system for assisting interventional treatment of aorto-coronary ostium lesions

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053869
Enrollment
Unknown
Registered
2021-12-01
Start date
2015-11-13
Completion date
Unknown
Last updated
2022-10-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

coronary heart disease

Interventions

Experimental group:intraoperative use of locators
Control group:using conventional method

Sponsors

Beijing Anzhen Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-80 years, gender is not limited; 2. Case selection: patients with aortic-coronary ostium lesions (lesions located in the left main coronary artery (LM) and right coronary artery (RCA) openings) requiring stenting (According to the Chinese guidelines for percutaneous coronary intervention 2012, judged by the investigator); 3. The patients volunteered to participate in this study and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Abnormal origin of coronary ostium; 2. Restenosis in the original stent at the opening; 3. Other operators think it is inappropriate to use this test device, such as the dilation of the coronary artery opening or the appearance of a horn; 4. Patients with ST-segment elevation myocardial infarction within 7 days; 5. Severe calcified lesions that cannot be adequately pre-expanded; 6. Left ventricular ejection fraction (LVEF) <= 35%; 7. Those who have participated in other clinical trials within 6 months; 8. The investigator judges other circumstances that are not suitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
the range of stent slippage when positioning (mm);

Secondary

MeasureTime frame
the extent of guiding catheters swing during stent positioning (mm);the rate of accurate stent placement;the procedure time;the incidence of major adverse cardiovascular events;

Countries

China

Contacts

Public ContactNie Shaoping

Beijing Anzhen Hospital Affiliated to Capital Medical University

spnie@126.com+86 13701186772

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026